Photometer LP 1

FDA 510(k) K801564 · Dr. Bruno Lange GmbH

Substantially Equivalent

510(k) numberK801564

Submission

Device name
Photometer LP 1
Applicant
Dr. Bruno Lange GmbH
Mchenry, IL, US
Received
July 8, 1980
Decision date
August 20, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JJQ – Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device class
Class I (low risk)
Regulation
21 CFR 862.2300
Specialty
Clinical Chemistry

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K962113Anthos Phacts Version Microplate ReaderJJQ · Traditional Columbia Bioscience, Inc.11/05/1996SE
K961183Cbi 7520 ReaderJJQ · Traditional Columbia Bioscience, Inc.08/02/1996SE
K962166Origen AnalyzerJJQ · Traditional Igen, Inc.07/31/1996SE
K955077Anthos 2010 ReaderJJQ · Traditional Anthos Labtec, Inc.12/04/1995SE
K953710ELX808 Automated Microplate ReadersJJQ · Traditional Bio-Tek Instruments, Inc.10/25/1995SE
K953572ELX800UVJJQ · Traditional Bio-Tek Instruments, Inc.10/19/1995SE

More from Bio-Tek Instruments, Inc.

510(k)DeviceDecision
K834226Flame PhotometersJJO · Traditional 06/22/1984SE
K832531Photometer LP 300JJQ · Traditional 12/12/1983SE
K801563Photometer LP 3JJQ · Traditional 08/20/1980SE
K801562Photometer LP 6JJQ · Traditional 08/20/1980SE

Questions and answers

When was Photometer LP 1 cleared by the FDA?

Photometer LP 1 (K801564) received a 510(k) decision of Substantially Equivalent on August 20, 1980, 43 days after the submission was received.

What is the product code of K801564?

The FDA product code is JJQ – Colorimeter, Photometer, Spectrophotometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2300.